The following data is part of a premarket notification filed by Sedecal Sa with the FDA for Mobilediagnost Wdr.
| Device ID | K141895 |
| 510k Number | K141895 |
| Device Name: | MOBILEDIAGNOST WDR |
| Classification | System, X-ray, Mobile |
| Applicant | SEDECAL SA 409 WOODRIDGE DR. Seneca, SC 29672 |
| Contact | Jennifer Cartledge |
| Correspondent | Jennifer Cartledge SEDECAL SA 409 WOODRIDGE DR. Seneca, SC 29672 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-14 |
| Decision Date | 2014-09-18 |
| Summary: | summary |